Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

Skin Cancer Clinical Trial

Official title:

Inhaled Essential Oil Effect on Common Quality of Life Concerns During Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858855
• Other study ID #: OSU-18136
• Secondary ID: NCI-2019-00340
• Status: Completed
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: April 13, 2020

Study information

• Verified date: July 2020
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This single-blind, randomized controlled trial studies how well inhaled essential oils work for common quality of life concerns in patients who are undergoing cancer treatment such as chemotherapy, targeted therapy, and/or immunotherapy given through the vein (intravenously). Aromatherapy using essential oils, such as ginger essential oil, German chamomile essential oil, and bergamot essential oil, may improve quality of life issues such as nausea, anxiety, loss of appetite, and fatigue in patients undergoing treatment for cancer.

Description:

PRIMARY OBJECTIVES:

I. To determine if aromatherapy, specifically inhaled essential oil, is beneficial for side effects related to cancer treatments involving chemotherapy, targeted therapy, and/or immunotherapy administered intravenously.

II. To describe the effect of inhaled ginger essential oil, German chamomile essential oil, and bergamot essential oil on nausea and anxiety of patients receiving chemotherapy, targeted therapy, and/or immunotherapy administered intravenously.

III. To describe the effect of decreased levels of nausea and/or anxiety on levels of appetite and/or fatigue.

IV. To evaluate the acceptability of using a personal inhalation bottle for inhalation of essential oils.

OUTLINE: Patients are randomized to 1 of 4 groups.

GROUP I: Patients inhale 7 drops of bergamot essential oil using a personalized inhalation bottle three times daily (TID) (morning, midday, and evening) for up to 7 days. Patients also use a journal to document symptoms, time of inhalation, and medication use TID for up to 7 days.

GROUP II: Patients inhale 7 drops of chamomile essential oil and complete journal as in group I.

GROUP III: Patients inhale 7 drops of ginger essential oil and complete journal as in group I.

GROUP IV (CONTROL): Patients inhale 7 drops of almond essential oil and complete journal as in group I.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: April 13, 2020
• Est. primary completion date: April 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Gastrointestinal cancers, neuroendocrine cancer, or melanoma or other skin cancers

• Receiving chemotherapy, targeted therapy, and/or immunotherapy

• Not naive to the treatment

• Must be able to read and write English

Exclusion Criteria:

• Allergies to ragweed, chrysanthemum, chamomile, ginger, bergamot, citrus fruits, tree nuts, perfumes

• Asthma diagnosis

• Patients receiving only octreotide injections

• Patients receiving floxuridine (FUDR) via hepatic artery infusion (HAI) pump only

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Neuroendocrine Carcinoma
• Skin Cancer
• Skin Neoplasms

Intervention

Procedure:
• Aromatherapy and Essential Oils
Use bergamot essential oil
• Aromatherapy and Essential Oils
Use chamomile essential oil
• Aromatherapy and Essential Oils
Use ginger essential oil
• Aromatherapy and Essential Oils
Use almond essential oil

Other:
• Subject Diary
Complete journal

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of essential oils on nausea and anxiety	Levels of nausea and anxiety will be measured using a numerical grading scale of 0-10. 0 will equal "good" meaning no nausea or anxiety. 10 will equal "horrible" meaning the worst nausea or anxiety. Data for each outcome will be collected 3 times a day, for a total of 21 measurements from each subject. For data analysis, we will compress the 21 measures into 3 scores. Each subject will be given a daily outcome level by averaging the 3 measures. The 7 daily outcome levels will become 3 scores by averaging data from days 1 and 2 (Period 1), days 3 and 4 (Period 2), and days 5, 6, and 7 (Period 3). Using the 3 scores, each outcome will be modeled using a repeated measures regression allowing the variability of outcome scores to vary with period. Period, group membership, the interaction between period and group membership, gender, age, and type of cancer will be model predictors. For each outcome, the contrast of interest will be that between each treatment group and the control group.	Up to 7 days
Secondary	Determine if decreased levels of nausea and/or anxiety effect appetite and/or fatigue	Anticipated results of the study are that patients will report decreased levels of nausea and anxiety. With the decreased levels of nausea and anxiety, we anticipate that patients will report increased levels of appetite and decreased levels of fatigue. Loss of appetite and fatigue will be measured using a numerical grading scale of 0-10. 0 will equal "good" meaning no loss of appetite or fatigue. 10 will equal "horrible" meaning the worst appetite loss or fatigue. Data will be collected, measured, and analyzed in the same manner as Outcome 1.	Up to 7 days
Secondary	Acceptability of using a personal inhalation bottle for inhalation of essential oils - ease of use	The overall ease of using the personal inhalation bottle will be measured through post-study ratings by participants. A numerical rating scale of 1-5 will be used. 1 will equal strongly disagree; 2 will equal disagree; 3 will equal neither agree nor disagree; 4 will equal agree; and 5 will equal strongly agree. The study will compare via a percentage those participants with positive acceptability when compared to those with negative acceptability.	Up to 7 days
Secondary	Acceptability of using a personal inhalation bottle for inhalation of essential oils - utilization post study period	The utilization of the personal inhalation bottle beyond the study period will be measured through post-study ratings by participants. A numerical rating scale of 1-5 will be used. 1 will equal strongly disagree; 2 will equal disagree; 3 will equal neither agree nor disagree; 4 will equal agree; and 5 will equal strongly agree. The study will compare via a percentage those participants with positive acceptability when compared to those with negative acceptability.	Up to 7 days
Secondary	Acceptability of using a personal inhalation bottle for inhalation of essential oils - perception of benefit of essential oil for symptoms	The overall perception of help for symptoms will be measured through post-study ratings by participants. A numerical rating scale of 1-5 will be used. 1 will equal strongly disagree; 2 will equal disagree; 3 will equal neither agree nor disagree; 4 will equal agree; and 5 will equal strongly agree. The study will compare via a percentage those participants with positive acceptability when compared to those with negative acceptability.	Up to 7 days

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